Ovarian clear cell adenocarcinoma

MENLO PARK, Calif., April 20, 2023 /PRNewswire/ -- Edison Oncology Holding Corp. ("Edison Oncology"), a privately held biopharmaceutical company, is pleased to announce the presentation of two scientific posters at the annual meeting of the American Association of Cancer Research held in Orlando, Florida from April 14-19. In a presentation entitled "A Pilot Clinical Trial of VAL-413 (Orotecan®, oral irinotecan HCl) in Patients with Recurrent Pediatric Solid Tumors," the company reported that, to date in its ongoing Phase 1-2a clinical trial, of Orotecan, a novel oral formulation of irinotecan, no dose limiting toxicity has been observed in patients receiving Orotecan, and preliminary analysis of pharmacokinetic data suggests that plasma levels of irinotecan and its active metabolite, SN-38, are similar to levels observed following treatment with unformulated commercially available i.v. irinotecan given orally in the same patient. In a second presentation entitled "Investigating the Therapeutic Efficacy of EO3001 in Clear Cell Carcinoma of the Ovary", Edison Oncology reported that in CRISPR/Cas9 generated isogenic pairs of ovarian cancer cell lines, EO3001 selectively kills ARID1A mutant cancer cells at low nanomolar concentrations compared to "wildtype" ovarian cancer cells that do not harbor the mutation. A mechanism of action of EO3001 in ARID1A mutant ovarian clear cell carcinoma (OCCC) is also proposed. Since ARID1A mutations are known to inactivate the SWI/SNF complex and expose the DNA into an "open chromatin" structure, such cells have high DNA replication and enhanced metabolic rates. To meet this enhanced energy need such cells become dependent on oxidative phosphorylation (OXPHOS). The poster describes that by directly inhibiting the action of certain mitochondrial proteins required for the function of the OXPHOS pathway, EO3001 may result in energy deprivation and apoptosis the of metabolically overactive ARID1A mutant tumor cells. About Orotecan® (oral irinotecan HCl) Orotecan is a novel oral liquid formulation of irinotecan hydrochloride designed to deliver the drug orally with improved tolerability. Irinotecan is an intravenous (i.v.) topoisomerase inhibitor approved by the FDA for the treatment of colorectal cancer and used 'off label' in the treatment of a several types of cancer including gastric cancers, neuroendocrine and adrenal tumors, pancreatic cancer, small cell lung cancer, cervical cancer, ovarian cancer, esophageal cancer, soft tissue sarcomas and bone cancer. A standard regimen of i.v. irinotecan for the treatment of childhood tumors involves daily infusions for five consecutive days, every two to three weeks leading to significant patient inconvenience, diminished quality of life and high cost to the healthcare system. "Orotecan's oral formulation has been developed to improve tolerability and patient compliance in the treatment of rare childhood tumors, with an opportunity to expand into major adult cancers," said Jeffrey Bacha, Edison Oncology's chief executive officer. "The data we have observed in our clinical trial thus far supports our confidence that Orotecan has the opportunity to address significant unmet needs in a number of tumors where i.v. irinotecan is currently utilized as a single agent, or in combination with oral anti-cancer treatments." To date, more than 200 patients have been treated with unformulated commercially available i.v. irinotecan delivered orally with promising results in the treatment of Ewing sarcoma and other pediatric cancers; however, poor palatability of the drug has limited the widespread adoption of this approach in clinical practice. Edison Oncology's ongoing clinical trial (clinicaltrials.gov identifier: NCT04337177) is designed to examine the safety and tolerability of Orotecan and provide data assess the pharmacokinetics of Orotecan compared to current oral regimen employing unformulated i.v. irinotecan given orally. About EO3001 EO3001 is a novel small-molecule drug candidate that has been studied in prior clinical trials involving more than 1000 patients. Recent research conducted by Edison Oncology and academic researchers has demonstrated EO3001 exhibits potent and selective activity against ARID1A deficient cancer cells. Mutations in ARID1A are associated with treatment resistance and poor outcomes in several cancers including gynecologic malignancies, breast cancer, gastric cancer, colorectal cancer and pancreatic cancer. Ovarian clear cell carcinoma (OCCC) is an orphan cancer indication representing approximately 10% of ovarian cancers in North America with a higher frequency in patients of east Asian descent. OCCC is inherently resistant to standard chemotherapy and radiation treatment and currently represents the worst prognosis of any form of epithelial ovarian cancer. "According to published studies up to 60% of OCCC patients harbor ARID1-A mutations, providing a readily available biomarker for patient selection in clinical trials," said Mr. Bacha. "We look forward to advancing EO3001 as a potential treatment for this important unmet medical need." About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and pharmacology to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. SOURCE Edison Oncology Holding Corp.

NXP800 Phase 1a Dose-Escalation Study Progressing as Planned, Commencement of Phase 1b Expansion Study Expected in Q1 2023 NXP800 IND Cleared by the U.S. FDA, U.S. and U.K. Sites Now Participating in the Clinical Program NXP900 IND-Enabling Work Progressing as Planned, Expected Completion by Year-End 2022 Recently Completed Private Placement Extends Cash Runway into H2 2024 FORT LEE, N.J., Aug. 05, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of novel therapies for the treatment of serious conditions of unmet medical need in oncology, today reported its financial results for the second quarter of 2022 and provided an update on recent business progress. “Nuvectis has made excellent progress this year towards its goal of becoming a leading precision medicine company with a robust, novel pipeline to treat unmet needs in oncology” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “The NXP800 Phase 1a dose-escalation study is proceeding as planned with the start of the Phase 1b expansion phase expected in Q1 2023. With the U.S. Food and Drug Administration’s (“FDA”) clearance of the NXP800 Investigational New Drug Application (“IND”), we now have clinical sites in the United States participating in the clinical program in addition to sites in the United Kingdom. We also look forward to sharing updates on new potential target indications, in addition to ovarian clear cell and ovarian endometrioid carcinoma, later this year.” Mr. Bentsur continued: “The body of evidence supporting the therapeutic potential of NXP900 continues to grow, and we are pleased with the recent preclinical data demonstrating robust activity of NXP900 in a xenograft model of Group 4 Medulloblastoma, a disease that affects mosrtly pediatric patients. We expect to complete the IND enabling studies by the end of this year.” Mr. Bentsur concluded: “The closing of a private placement earlier this month, coupled with our careful attention to spending, is expected to extend our cash runway into H2 2024. Based on the excellent second quarter progress, while leveraging our experienced team and expanded cash resources, I believe Nuvectis is well-positioned to potentially generate meaningful proof of concept data on its pipeline programs over the next year and beyond." Second Quarter Highlights NXP800 (our potentially first-in-class Heat Shock Factor 1 ("HSF1") pathway inhibitor): The Phase 1a dose escalation portion of the Phase 1 clinical program of NXP800 is ongoing and the Phase 1b dose expansion study is expected to begin in Q1 2023. The IND for NXP800 was cleared by the FDA, including the Phase 1 clinical trial protocol which is now enrolling patients in both the United States and the United Kingdom. Additional preclinical studies to identify new target indications for NXP800 are ongoing. An overview of the NXP800 drug discovery program was presented at the 2022 American Association for Cancer Research (“AACR”) Conference in the “New Drugs on The Horizon” oral session. The presentation included details on the unique program that led to the selection of NXP800 as a clinical candidate and on ovarian clear cell carcinoma and endometrioid ovarian carcinoma as the lead target indications. NXP900 (our novel, selective SRC/YES1 kinase inhibitor): IND-enabling studies for NXP900 are ongoing with expected completion by the end of 2022. Robust anti-cancer activity was demonstrated in a preclinical model of Group 4 Medulloblastoma (data presented at the European Society for Paediatric Oncology (“SIOPE”) Brain Tumor Group meeting in Hamburg, Germany). Preclinical data on NXP900 was presented at the 2022 AACR Conference. The presentation included data demonstrating that NXP900 is potent against cancer cells of squamous origin (prevalent in lung, head and neck, cervical, skin and esophageal malignancies) and the identification of mutations that are associated with NXP900 sensitivity. Financing In August 2022, the Company completed a private placement raising approximately $15.9 million in gross proceeds which is expected to extend the cash runway into H2 2024. Second Quarter 2022 Financial Results Cash, cash equivalents, and short-term investments were $13.6 million as of June 30, 2022, compared to $5.7 million as of December 31, 2021. The increase of $7.9 million was primarily a result of the Company’s initial public offering in February 2022. Research and development expenses were $2.5 million for the three months ended June 30, 2022, compared to $4.2 million for the three months ended June 30, 2021, a decrease of $1.7 million. The reduction in research and development expenses is primarily attributed to the payment of the NXP800 license fee in 2021. Research and development expenses for the second quarter 2022 included $0.3 million in non-cash expenses. General and administrative expenses were $1.1 million for the three months ended June 30, 2022, compared to $1.7 million for the three months ended June 30, 2021, a decrease of $0.6 million. The reduction in general and administrative expenses is primarily attributed to a reduction in professional and consulting fees. General and administrative expenses for the second quarter 2022 included $0.2 million in non-cash expenses. The Company's net loss was $3.6 million for the three months ended June 30, 2022, compared to $5.9 million for the three months ended June 30, 2021, a decrease of $2.4 million. Net loss for the second quarter of 2022 included $0.5 million in non-cash expenses as well as $0.5 million in non-recurring expenses. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates: NXP800, a clinical-stage HSF1 pathway inhibitor currently in a Phase 1 study in patients with advanced solid tumors, and NXP900, a novel SRC/YES1 kinase inhibitor currently in preclinical development with IND-enabling studies ongoing. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. For example, we are using forward-looking statements when we discuss the intended use of net proceeds from the private placement. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements is subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date with and the preclinical and clinical expectations for NXP800 and NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in the 2021 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact: Ron Bentsur Chairman, Chief Executive Officer and President 201-614-3151 rbentsur@nuvectis.com Media Relations Contact: Christopher M. Calabrese LifeSci Advisors Tel: 917-680-5608 ccalabrese@lifesciadvisors.com NUVECTIS PHARMA, INC. CONDENSED BALANCE SHEETS (USD in thousands, except per share and share amounts) (unaudited) June 30, December 31, 2022 2021 Assets CURRENT ASSETS: Cash and cash equivalents 13,572 5,742 Other current assets 666 91 TOTAL CURRENT ASSETS 14,238 5,833 Deferred offering costs — 824 TOTAL ASSETS 14,238 6,657 Liabilities, Redeemable Convertible Preferred Shares and Stockholders’ Equity (Deficit) Accounts payables 1,434 1,058 Payable offering costs 341 824 Accrued liabilities 790 395 Employee compensation and benefits 173 142 TOTAL CURRENT LIABILITIES 2,738 2,419 TOTAL LIABILITIES 2,738 2,419 COMMITMENTS AND CONTINGENCIES, see Note 3 REDEEMABLE CONVERTIBLE PREFERRED SHARES: Convertible preferred A stock, $0.00001 par value – Zero and 6,630,000 shares authorized as of June 30, 2022 and December 31, 2021, respectively. As of June 30, 2022 all issued and outstanding preferred A stock was converted to common stock. As of December 31, 2021, 5,012,280 preferred A stock shares were issued and outstanding. — 15,246 STOCKHOLDERS’ EQUITY (DEFICIT), see Note 4: Common Stock, $0.00001 par value – 60,000,000 and 12,870,000 shares authorized as of June 30, 2022 and December 31, 2021, respectively 12,717,794 and 4,505,514 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively * * Additional paid in capital 30,912 1,892 Notes received for common shares — (*) Accumulated deficit (19,412) (12,900 ) TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) 11,500 (11,008 ) TOTAL LIABILITIES, REDEEMABLE COVERTIBLE PREFERRED SHARES AND STOCKHOLDERS’ EQUITY (DEFICIT) 14,238 6,657 * Represents an amount lower than $1,000 USD. NUVECTIS PHARMA, INC. CONDENSED STATEMENTS OF OPERATIONS (USD in thousands, except per share and share amounts) (unaudited) Three Months Ended June 30 Six Months Ended June 30 2022 2021 2022 2021 OPERATING EXPENSES: RESEARCH AND DEVELOPMENT 2,505 4,245 4,310 4,245 GENERAL AND ADMINISTRATIVE 1,068 1,693 2,208 1,716 OPERATING LOSS (3,573) (5,938) (6,518) (5,961) FINANCE INCOME 4 — 6 — NET LOSS (3,569) (5,938) (6,512) (5,961) NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS (3,569) (5,938) (6,512) (5,961) BASIC AND DILUTED NET LOSS PER COMMON SHARE OUTSTANDING, see Note 6 (0.28) (1.43) (0.59) (1.48) BASIC AND DILUTED WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 12,717,794 4,155,661 10,984,090 4,027,124

FORT LEE, NJ,, June 21, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (“Nuvectis”, “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (“FDA”) cleared the Company's Investigational New Drug Application (“IND”) for NXP800, which includes the Phase 1 clinical trial protocol. The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (“Phase 1a”) to be followed by an expansion study (“Phase 1b”). The Phase 1a is currently ongoing in the United Kingdom (“U.K.”) and, with the IND in effect, U.S. clinical sites will now be included. The Company expects to initiate the Phase 1b study in early 2023. “The FDA approval of the IND for NXP800 marks an important milestone towards our mission of developing novel treatments for unmet medical needs in oncology” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “We continue to effectively execute our clinical development strategy for NXP800, with the hope of it becoming the first drug approved for ARID1a-mutated ovarian clear cell carcinoma and endometrioid ovarian carcinoma, and potentially for additional cancers of unmet medical need.” Mr. Bentsur added, “We look forward to building on the substantial interest that NXP800 has garnered in the medical community and to working with leading clinical centers in the U.S. and the U.K. on this important project.” Mr. Bentsur concluded, "With the progress that we continue to make with NXP800 and NXP900, our novel, oral and highly-specific SRC/YES1 kinase inhibitor, which is expected to enter the clinic in early 2023, we believe that we are emerging as an exciting precision medicine company." About NXP800 Nuvectis licensed exclusive world-wide rights to NXP800, a novel, oral Heat Shock Factor 1 (“HSF1”) pathway inhibitor, which was discovered at the Institute of Cancer Research in London, England. The HSF1 pathway is implicated in cancer cell growth, metastasis, and survival across several types of cancer. In preclinical studies, NXP800 demonstrated potent anti-proliferative activity against a variety of cancer cell lines, and inhibited tumor growth in ARID1A-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma human xenograft models. Nuvectis is conducting further in vivo studies to evaluate the potential use of NXP800 in additional tumor types, including gastric, liver and esophageal cancers, with and without mutations in ARID1a and other biomarkers. NXP800 is currently in a Phase 1 clinical trial that is comprised of two parts: dose-escalation Phase 1a, to be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 is being evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b study, the safety and preliminary anti-tumor activity of NXP800 will be evaluated, initially in Arid1a-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma, Nuvectis expects to include additional arms in the Phase 1b study based on the results of the ongoing in-vivo studies in other tumor types. The Company plans to initiate the Phase 1b in early 2023. NXP800 has the potential to become a first-in-class inhibitor of the HSF1 pathway. About Nuvectis Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company's pipeline includes NXP800, a clinical-stage HSF1-pathway inhibitor, and NXP900, a SRC/YES1 kinase inhibitor in IND-enabling studies. For more information, please visit www.nuvectis.com. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date, and the clinical expectations for NXP800 and NXP900 including NXP800's potential ability to become a therapeutic option for the treatment of ovarian clear cell carcinoma, ovarian endometrioid carcinoma and potentially other cancer indications. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in the 2021 Form 10-K filed with the Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Nuvectis Pharma Contact: Ron Bentsur Chairman, Chief Executive Officer and President rbentsur@nuvectis.com Media Relations Contact: Christopher M. Calabrese LifeSci Advisors Tel: 917-680-5608 ccalabrese@lifesciadvisors.com